Research Roundup: Lasting Immunity to COVID-19 and More – BioSpace

By daniellenierenberg

Every week there are numerous scientific studies published. Heres a look at some of the more interesting ones.

Multiple Studies Suggest Lasting Immunity to COVID-19 After Infection

Although probably not enough time has passed to know definitively, several studies are now suggesting that even mild cases of COVID-19 stimulate lasting immune responses, not only in disease-fighting antibodies, but in B- and T-cells.

Things are really working as theyre supposed to, Deepta Bhattacharya, an immunologist at the University of Arizona, and an author of one of the studies, told The New York Times.

Its difficult, probably impossible, to predict how long those immune responses will last, but many of the researchers believe the results are promising for long-term protection.

This is exactly what you would hope for, Marion Pepper, an immunologist at the University of Washington and an author of a study currently being reviewed by the journal Nature. All the pieces are there to have a totally protective immune response.

Pepper notes that the protective effects cant be completely evaluated until there is proof that people exposed to the virus a second time can fight it off. But the data suggests the immune system is indeed able to fight resistance a second time. Some of this qualification comes from unconfirmed reports of people being reinfected by the virus.

Antibody responses are typically relatively short-lived, disappearing from the blood weeks or months after being produced. Generally, the majority of the B-cells that produce antibodies die off, too. But the body keeps some longer-lived B-cells that are able to manufacture virus-fighting antibodies should the immune system be triggered by re-exposure to the virus. Some stay in the bloodstream while others wait in the bone marrow where they manufacture small numbers of antibodies that can sometimes be observed years, even decades later. Several studies, some by Bhattacharya and Pepper, have identified antibodies at low levels in the blood months after people recovered from COVID-19.

The antibodies decline, but they settle in what looks like a stable nadir, Bhattacharya said. These have been observed about three months after symptoms show up. The response looks perfectly durable.

Additional studies, including one published in the journal Cell, have isolated T-cells from recovered patients that can attack SARS-CoV-2. In laboratory studies, the T-cells produced signals to fight the virus and cloned themselves in large numbers to fight the potential infection.

This is very promising, said Smita Iyer, an immunologist at the University of California, Davis, who was not involved in the new studies, but has researched immune responses to the novel coronavirus in rhesus macaques. This calls for some optimism about herd immunity, and potentially a vaccine.

It's still has not been definitely determined if milder cases of COVID-19 will lead to long-term or even medium-term immunity. There have been some studies that suggest it does not and some newer studies suggesting it does. Iyer notes that the recent paper indicates, You can still get durable immunity without suffering the consequences of infection.

This idea is reinforced by Eun-Hyung Lee, an immunologist at Emory University who was not involved in these studies. He told The New York Times, Yes, you do develop immunity to this virus, and good immunity to this virus. Thats the message we want to get out there.

Why Seasonal Flu Vaccines Only Last a Year

As most everyone knows, flu vaccines only last about a year. Some of this is related to viral mutations. But in fact, the actual immunity itself caused by the vaccine does not appear to last longer than a year, even though the flu vaccine increases the number of antibody-producing cells specific for the flu in the bone marrow. Researchers out of Emory Vaccine Center found that for most newly-generated plasma cell lineages, between 70 and 99% of the cells were gone after one year, but that the levels of antibody-secreting cells in blood correlated with long-term response in the bone marrow.

Gut Bacteria Can Help Immuno-Oncology Therapies

Researchers with the University of Calgary identified gut bacteria that help our immune system fight cancerous tumors. This also helped provide more information about why immunotherapy works in some cases, but not others. By combining immunotherapy with specific microbial therapy, they believe they can help the immune system and immunotherapy be more effective in treating three types of cancer: melanoma, bladder and colorectal cancers. They found that specific bacteria were essential for immunotherapy to work in colorectal cancer tumors in germ-free mice. The bacteria produced a small molecule called inosine that interacts directly with T-cells and together with immunotherapy.

An Online Calculator to Predict Stroke Risk

Scientists at the University of Virginia Health System developed an online tool that measures the severity of a patients metabolic syndrome, a mix of conditions that includes high blood pressure, abnormal cholesterol levels and excess body fat. With it, they can then predict the patients risk for ischemic stroke. The study discovered that stroke risk increased consistently with metabolic syndrome severity even in patients that did not have diabetes. The tool is available for free at https://metscalc.org/.

A Link Between Autism and Cholesterol

Researchers at Harvard Medical School, Massachusetts Institute of Technology (MIT) and Northwestern University identified a subtype of autism that is the result of a cluster of genes that regulate cholesterol metabolism and brain development. They believe this information can help design precision-targeted therapies for this specific type of autism and improve screening efforts for earlier diagnosis of autism. They analyzed the DNA from brain samples that they then confirmed with the medical records of autistic individuals. They found that children with autism and their parents had significant alterations in lipid blood. However, there is much more to be understood, emphasizing the complexity of autism, which is affected by a variety of genetic and environmental factors.

Researchers Grow First Functioning Mini Human Heart Model

Investigators with Michigan State University grew the first miniature human heart model in the laboratory that is complete with all primary heart cell types and a functioning structure of chambers and vascular tissue. They utilized induced pluripotent stem cells which were obtained from consenting adults and created a functional mini heart in a few weeks. The primary value was in giving them an unprecedented view into how a fetal heart develops.

In the lab, we are currently using heart organoids to model congenital heart diseasethe most common birth defect in humans affecting nearly 1% of the newborn population, said Aitor Aguirre, senior author and assistant professor of biomedical engineering at MSUs Institute for Quantitative Health Science and Engineering. With our heart organoids, we can study the origin of congenital heart disease and find ways to stop it.

Another area of focus is that improving on the final organoid will help with future research. Current heart organoids are not identical yet to human hearts and so are flawed in their use as research models.

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Research Roundup: Lasting Immunity to COVID-19 and More - BioSpace

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August 22nd, 2020

Cell Therapy Manufacturing Market 2020 Report Including COVID-19 Impact Analysis and Forecast till 2029 – Scientect

By daniellenierenberg

The research study on Global Cell Therapy Manufacturing market 2019 presents an extensive analysis of current Cell Therapy Manufacturing market size, drivers, trends, opportunities, challenges, as well as key Cell Therapy Manufacturing market segments. Further, it explains various definitions and classification of the Cell Therapy Manufacturing industry, applications, and chain structure.In continuation of this data, the Cell Therapy Manufacturing report covers various marketing strategies followed by key players and distributors. Also explains Cell Therapy Manufacturing marketing channels, potential buyers and development history. The intent of global Cell Therapy Manufacturing research report is to depict the information to the user regarding Cell Therapy Manufacturing market forecast and dynamics for the upcoming years.The Cell Therapy Manufacturing study lists the essential elements which influence the growth of Cell Therapy Manufacturing industry. Long-term evaluation of the worldwide Cell Therapy Manufacturing market share from diverse countries and regions is roofed within the Cell Therapy Manufacturing report. Additionally, includes Cell Therapy Manufacturing type wise and application wise consumption figures.

The Final Report will cover the impact analysis of COVID-19 on this industry.

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After the basic information, the global Cell Therapy Manufacturing Market study sheds light on the Cell Therapy Manufacturing technological evolution, tie-ups, acquisition, innovative Cell Therapy Manufacturing business approach, new launches and Cell Therapy Manufacturing revenue. In addition, the Cell Therapy Manufacturing industry growth in distinct regions and Cell Therapy Manufacturing R&D status are enclosed within the report.The Cell Therapy Manufacturing study also incorporates new investment feasibility analysis of Cell Therapy Manufacturing. Together with strategically analyzing the key micro markets, the report also focuses on industry-specific drivers, restraints, opportunities, and challenges in the Cell Therapy Manufacturing market.

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Global Cell Therapy Manufacturing Market Segmentation 2019:The study also classifies the entire Cell Therapy Manufacturing market on basis of leading manufacturers, different types, various applications and diverse geographical regions.Overall Cell Therapy Manufacturing market is characterized by the existence of well-known global and regional Cell Therapy Manufacturing vendors. These established Cell Therapy Manufacturing players have huge essential resources and funds for Cell Therapy Manufacturing research as well as developmental activities. Also, the Cell Therapy Manufacturing manufacturers focusing on the development of new Cell Therapy Manufacturing technologies and feedstock. In fact, this will enhance the competitive scenario of the Cell Therapy Manufacturing industry.

The Leading Players involved in global Cell Therapy Manufacturing market are:harmicell, Merck Group, Dickinson and Company, Thermo Fisher, Lonza Group, Miltenyi Biotec GmBH, Takara Bio Group, STEMCELL Technologies, Cellular Dynamics International, Becton, Osiris Therapeutics, Bio-Rad Laboratories, Inc., Anterogen, MEDIPOST, Holostem Terapie Avanazate, Pluristem Therapeutics, Brammer Bio, CELLforCURE, Gene Therapy Catapult EUFETS, MaSTherCell, PharmaCell, Cognate BioServices and WuXi AppTec.

Based on Therapy Type, the Cell Therapy Manufacturing market is categorized into: Allogeneic Cell Therapy Autologous Cell Therapy

Based on Technology, the Cell Therapy Manufacturing market is categorized into: Somatic Cell Technology Cell Immortalization Technology Viral Vector Technology Genome Editing Technology Cell Plasticity Technology 3D Technology

Based on Source, the Cell Therapy Manufacturing market is categorized into: IPSCs Bone Marrow Umbilical Cord Adipose Tissue Neural Stem Cells

Based on Application, the Cell Therapy Manufacturing market is categorized into: Musculoskeletal Cardiovascular Gastrointestinal Neurological Oncology Dermatology Other

Global Cell Therapy Manufacturing Market Regional Analysis:The companies in the world that deals with Cell Therapy Manufacturing mainly concentrate following regions.North America, Europe, Asia Pacific, Latin America, and Middle East & AfricaGlobal Cell Therapy Manufacturing Industry Report Covers following Topics:01: Cell Therapy Manufacturing Market Overview02: Global Cell Therapy Manufacturing Sales, Revenue (value) and Market Share by Players03: Cell Therapy Manufacturing Market Sales, Revenue (Value) by Regions, Type and Application (2014-2018)04: Region wise Top Players Cell Therapy Manufacturing Sales, Revenue and Price05: worldwide Cell Therapy Manufacturing Industry Players Profiles/Analysis06: Cell Therapy Manufacturing Cost Analysis07: Industrial Chain, Cell Therapy Manufacturing Sourcing Strategy and Downstream Buyers08: Cell Therapy Manufacturing Marketing Strategy Analysis, Distributors/Traders09: Cell Therapy Manufacturing Industry Effect Factors Analysis10: Global Cell Therapy Manufacturing Market Forecast (2019-2026)11: Cell Therapy Manufacturing Research Findings and Conclusion12: Appendix

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Worldwide Cell Therapy Manufacturing Market Different Analysis:Competitors Review of Cell Therapy Manufacturing Market: Report presents the competitive landscape scenario seen among top Cell Therapy Manufacturing players, their company profile, revenue, sales, business tactics and forecast Cell Therapy Manufacturing industry situations.Production Review of Cell Therapy Manufacturing Market: It illustrates the production volume, capacity with respect to major Cell Therapy Manufacturing regions, application, type, and the price.

Sales Margin and Revenue Accumulation Review of Cell Therapy Manufacturing Market: Eventually explains sales margin and revenue accumulation based on key regions, price, revenue, and Cell Therapy Manufacturing target consumer.

Supply and Demand Review of Cell Therapy Manufacturing Market: Coupled with sales margin, the report depicts the supply and demand seen in major regions, among key players and for every Cell Therapy Manufacturing product type. Also interprets the Cell Therapy Manufacturing import/export scenario.

Other key reviews of Cell Therapy Manufacturing Market: Apart from the above information, correspondingly covers the company website, number of employees, contact details of major Cell Therapy Manufacturing players, potential consumers and suppliers. Also, the strengths, opportunities, Cell Therapy Manufacturing market driving forces and market restraints are studied in this report.

Highlights of Global Cell Therapy Manufacturing Market Report:* This report provides in detail analysis of the Cell Therapy Manufacturing and provides market size (US$ Million) and Cumulative Annual Growth Rate (CAGR (%)) for the forecast period: 2019 2029.* It also elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for world Cell Therapy Manufacturing market.* This study also provides key insights about Cell Therapy Manufacturing market drivers, restraints, opportunities, new product launches, approvals, regional outlook, and competitive strategies adopted by the leading Cell Therapy Manufacturing players.* It profiles leading players in the worldwide Cell Therapy Manufacturing market based on the following parameters company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments and strategies and future plans.* Insights from Cell Therapy Manufacturing report would allow marketers and management authorities of companies to make an informed decision with respect to their future product launches, market expansion, and Cell Therapy Manufacturing marketing tactics.* The world Cell Therapy Manufacturing industry report caters to various stakeholders in Cell Therapy Manufacturing market. That includes investors, device manufacturers, distributors and suppliers for Cell Therapy Manufacturing equipment. Especially incorporates government organizations, Cell Therapy Manufacturing research and consulting firms, new entrants, and financial analysts.*Various strategy matrices used in analyzing the Cell Therapy Manufacturing market would provide stakeholders vital inputs to make strategic decisions accordingly.Global Cell Therapy Manufacturing Market Report Provides Comprehensive Analysis of Following: Cell Therapy Manufacturing Market segments and sub-segments Industry size & Cell Therapy Manufacturing shares Cell Therapy Manufacturing Market trends and dynamics Market Drivers and Cell Therapy Manufacturing Opportunities Supply and demand of world Cell Therapy Manufacturing industry Technological inventions in Cell Therapy Manufacturing trade Cell Therapy Manufacturing Marketing Channel Development Trend Global Cell Therapy Manufacturing Industry Positioning Pricing and Brand Strategy Distributors/Traders List enclosed in Positioning Cell Therapy Manufacturing Market.

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Moreover, the report organizes to provide essential information on current and future Cell Therapy Manufacturing market movements, organizational needs and Cell Therapy Manufacturing industrial innovations. Additionally, the complete Cell Therapy Manufacturing report helps the new aspirants to inspect the forthcoming opportunities in the Cell Therapy Manufacturing industry. Investors will get a clear idea of the dominant Cell Therapy Manufacturing players and their future forecasts.

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Kenneth Research provides market research reports to different individuals, industries, associations and organizations with an aim of helping them to take prominent decisions. Our research library comprises of more than 10,000 research reports provided by more than 15 market research publishers across different industries. Our collection of market research solutions covers both macro level as well as micro level categories with relevant and suitable market research titles. As a global market research reselling firm, Kenneth Research provides significant analysis on various markets with pure business intelligence and consulting services on different industries across the globe. In addition to that, our internal research team always keep a track on the international and domestic market for any economic changes impacting the products demand, growth and opportunities for new and existing players.

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Cell Therapy Manufacturing Market 2020 Report Including COVID-19 Impact Analysis and Forecast till 2029 - Scientect

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August 22nd, 2020

Cell Therapy Processing Market is Booming Worldwide to Show Significant Growth by 2026 Cell Therapies Pty Ltd,Invitrx Inc.,Lonza Ltd,Merck & Co.,…

By daniellenierenberg

Cell therapy is the administration of living cells to replace a missing cell type or to offer a continuous source of a necessary factor to achieve a truly meaningful therapeutic outcome. There are different forms of cell therapy, ranging from transplantation of cells derived from an individual patient or from another donor. The manufacturing process of cell therapy requires the use of different products such as cell lines and instruments. These cell therapies are used for the treatment of various diseases such as cardiovascular disease and neurological disorders.

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Key Players:

Cell Therapies Pty Ltd,Invitrx Inc.,Lonza Ltd,Merck & Co., Inc. (FloDesign Sonics),NantWorks, LLC,Neurogeneration, Inc.,Novartis AG,Plasticell Ltd.,Regeneus Ltd,StemGenex, Inc.

Increase in the incidence of cardiovascular diseases, rise in the demand for chimeric antigen receptor (CAR) T cell therapy, increase in the R&D for the advancement in the research associated with cell therapy, increase in the potential of cell therapies in the treatment of diseases associated with lungs using stem cell therapies, and rise in understanding of the role of stem cells in inducing development of functional lung cells from both embryonic stem cells (ESCs) & induced pluripotent stem (iPS) cells are the key factors that fuel the growth of the cell therapy processing market.

Moreover, increase in a number of clinical studies relating to the development of cell therapy processing, rise in adoption of regenerative drug, introduction of novel technologies for cell therapy processing, increase in government investments for cell-based research, increase in number of GMP-certified production facilities, large number of oncology-oriented cell-based therapy clinical trials, and rise in the development of allogeneic cell therapy are other factors that augment the growth of the market. However, high-costs associated with the cell therapies, and bottlenecks experienced by manufacturers during commercialization of cell therapies are expected to hinder the growth of the market.

The cell therapy processing market is segmented into offering type, application, and region. By type, the market is categorized into products, services, and software. The application covered in the segment include cardiovascular devices, bone repair, neurological disorders, skeletal muscle repair, cancer, and others. On the basis of region, the market is analyzed across North America (U.S., Canada, and Mexico), Europe (Germany, France, UK, Italy, Spain, and rest of Europe), Asia-Pacific (Japan, China, India, and rest of Asia-Pacific), and LAMEA (Latin America, Middle East, and Africa).

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KEY MARKET SEGMENTS

By Offering Type Products Services Software

By Application Cardiovascular Devices Bone Repair Neurological Disorders Skeletal Muscle Repair Cancer Others

By Region

North Americao U.S.o Canadao Mexico Europeo Germanyo Franceo UK

Key question and answered in the report include:

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Cell Therapy Processing Market is Booming Worldwide to Show Significant Growth by 2026 Cell Therapies Pty Ltd,Invitrx Inc.,Lonza Ltd,Merck & Co.,...

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August 22nd, 2020

Steadman Philippon Research Institute (SPRI) Receives Multi-Million-Dollar Matching Grant from the National Institutes of Health – Yahoo Finance

By daniellenierenberg

Dr. Johnny Huard will be the Principal Investigator on five-year clinical trial that focuses on Bone Marrow Stem Cell treatments to delay onset of osteoarthritis in the knee

VAIL, Colorado, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Steadman Philippon Research Institute (SPRI) has been granted the prestigious Regenerative Medicine Innovation Project Investigator-Initiated Clinical Trials award from the National Institutes of Health (NIH). SPRI Chief Scientific Officer Johnny Huard, Ph.D. will serve as the principal investigator. Marc J. Philippon, M.D., who serves as managing partner of The Steadman Clinic and co-chair of SPRI and Scott Tashman, Ph.D., director of biomedical engineering at SPRI, will serve as co-principal investigators. The clinical trials are expected to begin enrolling in the Fall of 2020.

The award, administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, ranks as one of the most significant in SPRIs history, both in size and recognition. Given the potential of regenerative medicine to enhance human health and treat disease, the United States Congress included a provision in the 21st Century Cures Act a law passed in December 2016 to accelerate medical discovery and innovation to support the NIH-established Regenerative Medicine Innovation Project (RMIP). The RMIP aims to accelerate the field by supporting clinical research on adult stem cells while promoting the highest standards for protecting patient safety during the conduct of research.

This is a really great honor for SPRI, said Dr. Huard, who first came to Vail in 2015 and has served as the director of the Center for Regenerative Sports Medicine in addition to his role as the institutes chief scientific officer. Past recipients of these RMIP awards have been Albert Einstein College of Medicine, Boston Childrens Hospital, Columbia University Health Sciences, Childrens Hospital of Philadelphia, Harvard University, University of Colorado Denver and Yale University.So, we are in very good company.

The grant anticipates over $2.8 million from the NIH and requires a 1:1 match from SPRI over the next five years, pending availability of federal funds. The clinical trials and resulting publications and reports will take place over the next five years. A generous SPRI benefactor committed to fund the first year of the match, and Dr. Huard is hopeful that with the NIH matching the funds, more philanthropists will be inspired to become involved in this groundbreaking project.

Our donors have been so generous in supporting all that we do here at SPRI, said Dr. Huard, and I am very grateful and confident that we will raise the funds necessary to complete these trials over the next five years.

The trial is entitled,The Use of Senolytic and Anti-Fibrotic Agents to Improve the Beneficial Effect of Bone Marrow Stem Cells for Osteoarthritis. Huard explains in laypersons terms:

The idea behind the trial is to delay osteoarthritis in the knee, said Huard. Our goal is to delay the need for that first knee replacement in a patient for as long as we can. Over time SPRI intends to expand this area of research to other joints including hip and shoulder.

This clinical trial is designed to determine whether senolytic and/or antifibrotic agents will improve the beneficial effect of Bone Marrow Stem Cells for the treatment of symptomatic knee osteoarthritis. The trial will include four groups, totaling 100 patients, to investigate the teams hypothesis that the use of these agents will improve patient outcomes.

One of the great things that I love about this particular clinical trial is that we are actively involving our orthopaedic surgeons and our biomotion lab staff as well, said Dr. Huard. This will truly be a team effort over the next five years.

Those world-class surgeons are led by Dr. Philippon, considered one of the worlds foremost orthopaedic surgeons. The biomotion lab is under the direction of Dr. Tashman. The contributions of these two leaders and the talented roster of surgeons, clinicians and technicians in their departments will be critical to the success of the upcoming clinical trials. SPRIs Center for Outcomes-Based Orthopaedic Research and its director Grant Dornan are also participating in this project by contributing the statistical outcomes.

Story continues

Dr. Philippon is not only a world-class surgeon but he is also an innovator, added Dr. Huard. He always wants to improve and is still willing to try new things to enhance patient outcomes. Dr. Tashman is the same way. Like everyone here at SPRI and The Steadman Clinic, they are embracing the cutting-edge technology available to them and finding new and better ways to treat patients and, most importantly, reduce patients recovery time and get them back to their active lives as quickly and safely as possible.

Huard notes that the rare combination of a globally recognized research institute like SPRI and a world-class orthopaedic surgery clinic like The Steadman Clinic in the same building is one of the key factors in the awarding of this RMIP grant.

Weve got something here in Vail that many other research institutes dont have, said Huard. We have one of the worlds finest orthopaedic clinics right next door, working hand-in-hand with us every day.

Dr. Huard and Dr. Tashman along with Suzanne Liv Page, J.D., our director of grants and contracts have worked diligently to prepare and gain acceptance of this grant proposal from the NIH, said Dr. Philippon. Our surgeons here at The Steadman Clinic eagerly await the opportunity to participate in the trial. Johnny, Scott and their staff have put SPRI into position to undertake major trials and studies like this one and we are all very honored that the NIH has given SPRI this incredible opportunity.

For further information or other inquiries about The Steadman Clinic or Steadman Philippon Research Institute, contact Lynda Sampson, Vice President of External Affairs (lsampson@sprivail.org).

Link to current SPRI clinical trials - https://www.sprivail.org/about-us/clinical-trials

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August 20th, 2020

U.S. FDA Advisory Committee Votes Nine to One in Favor of Remestemcel-L (Ryoncil) for Efficacy in Children With Steroid-Refractory Acute Graft Versus…

By daniellenierenberg

NEW YORK, Aug. 14, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Drug Administration (FDA) voted overwhelmingly in favor that the available data support the efficacy of remestemcel-L (RYONCIL) in pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).

Mesoblast Chief Medical Officer Dr Fred Grossman said: Steroid-refractory acute graft versus host disease is an area of extreme need, especially in vulnerable children under 12 years old where there is no approved therapy. We are very encouraged by todays outcome and are committed to working closely with the FDA as they complete their review of our submission regarding approval of RYONCIL for this life-threatening complication of an allogeneic bone marrow transplant.

The ODAC is an independent panel of experts that evaluates efficacy and safety of data and makes appropriate recommendations to the FDA.Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made solely by the FDA, and the recommendations by the panel are non-binding. RYONCIL has been accepted for Priority Review by the FDA with an action date of September 30, 2020, under the Prescription Drug User Fee Act (PDUFA). If approved by the PDUFA date, Mesoblast plans to launch RYONCIL in the United States in 2020.

Pediatric transplant physician Dr Joanne Kurtzberg, the Jerome Harris Distinguished Professor of Pediatrics and Professor of Pathology, and Director, Pediatric Blood and Marrow Transplant Program at Duke University Medical Center, said: This devastating condition has an extremely poor prognosis and there are no FDA-approved options for children under the age of 12. The clinical studies I have directed have demonstrated the potential for this treatment to fill a significant unmet medical need.

Conference CallAn audio webcast can be accessed via https://webcast.boardroom.media/mesoblast-limited/20200813/NaN5f3237e85300840019de909d

The archived webcast is also available on the Investor page of the Companys website http://www.mesoblast.com

About Acute Graft Versus Host Disease Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.1 In patients with the most severe form of acute GVHD (Grade C/D or III/IV) mortality is as high as 90% despite optimal institutional standard of care.2,3 There are currently no FDA-approved treatments in the United States for children under 12 with SR-aGVHD, a potentially life-threatening complication of an allogeneic bone marrow transplant for blood cancer.

About RYONCILTM Mesoblasts lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in steroid-refractory acute graft versus host disease by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

1. Niederwieser D, Baldomero H, Szer J. Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey. Bone Marrow Transplant 2016; 51(6):778-85. 2. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory acute GVHD: predictors and outcomes. Advances in Hematology 2011;2011:601953. 3. Axt L, Naumann A, Toennies J (2019) Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantation. Bone Marrow Transplantation 2019;54(11):1805-1814

About MesoblastMesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblasts Biologics License Application to seek approval of its product candidate RYONCIL (remestemcel-L) for pediatric steroid-refractory acute graft versus host disease (acute GVHD) has been accepted for priority review by the United States Food and Drug Administration (FDA), and if approved, product launch in the United States is expected in 2020. Remestemcel-L is also being developed for other inflammatory diseases in children and adults including moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals (including any decision that the FDA may make based upon the recommendation of the ODAC in relation to the efficacy of remestemcel-L), manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For further information, please contact:

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U.S. FDA Advisory Committee Votes Nine to One in Favor of Remestemcel-L (Ryoncil) for Efficacy in Children With Steroid-Refractory Acute Graft Versus...

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August 20th, 2020

Genmab Announces Janssen Granted US FDA Approval for DARZALEX (daratumumab) in Combination with Carfilzomib and Dexamethasone in Relapsed or…

By daniellenierenberg

Company Announcement

Copenhagen, Denmark; August 20, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX (daratumumab) in combination with carfilzomib and dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. A supplemental Biologics License Application (sBLA) for this indication was submitted by Genmabs licensing partner, Janssen Biotech, Inc. (Janssen), in February 2020. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

We are extremely pleased that multiple myeloma patients in the U.S. will now have yet another treatment option as this is the eighth overall U.S. FDA approval for DARZALEX and the fifth in the relapsed/refractory setting. In addition, DARZALEX is now the first CD38 antibody approved for use in combination with carfilzomib, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The combination has been approved in two carfilzomib dosing regimens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on positive results from the Phase 3 CANDOR and Phase 1b EQUULEUS studies. CANDOR was an Amgen-sponsored study, co-funded by Janssen Research & Development, LLC. EQUULEUS was sponsored by Janssen Research & Development, LLC.

About the CANDOR studyThe Phase 3 trial (NCT03158688) was a randomized, open-label study that included 466 patients with multiple myeloma who had relapsed after 1 to 3 prior therapies. Patients were randomized to receive either DKd or carfilzomib and dexamethasone (Kd) alone. In the daratumumab treatment arm, patients received 8 milligrams per kilogram (mg/kg) on days 1 and 2 of cycle 1, then 16 mg/kg once weekly for the remaining doses of the first 2 cycles, then every 2 weeks for 4 cycles (cycles 3 to 6), and then every 4 weeks for the remaining cycles or until disease progression. In both treatment arms carfilzomib was dosed twice weekly (20 mg/m2 on cycle 1 days 1 and 2 and 56 mg/m2 beginning on cycle 1 day 8 and thereafter) and dexamethasone was given weekly (40 mg orally or via IV infusion). The primary endpoint of the study was progression free survival (PFS).

About the EQUULEUS (MMY1001) Study The Phase 1b EQUULEUS (NCT01998971) study was an open label, multi-cohort trial that evaluated the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of multiple myeloma. Among the regiments evaluated, the combination of DKd compared to Kd alone was studied in 85 patients with relapsed/refractory multiple myeloma who had received one to three prior lines of therapy using a once-weekly dosing regimen. DKd was evaluated at a starting dose of 20 mg/m2, which was increased to 70 mg/m2 on Cycle 1, Day 8 and onward.

About multiple myelomaMultiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were expected to be diagnosed with multiple myeloma and approximately 13,650 people were expected to die from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX (daratumumab)DARZALEX (daratumumab) has become a backbone therapy in the treatment of multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with carfilzomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy; in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

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DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy7. Daratumumab is the first subcutaneous CD38 antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.8 DARZALEX FASPRO is the first subcutaneous CD38 antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,9,10,11,12

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of the following approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Kesimpta (subcutaneous ofatumumab, under agreement with Novartis AG), for the treatment of adults with relapsing forms of multiple sclerosis in the U.S. and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. The first approved Genmab created therapy, Arzerra (ofatumumab, under agreement with Novartis AG), approved for the treatment of certain chronic lymphocytic leukemia indications, is available in Japan and is also available in other territories via compassionate use or oncology access programs. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. Arzerra and Kesimpta are trademarks of Novartis AG or its affiliates. DARZALEX and DARZALEX FASPRO are trademarks of Janssen Pharmaceutica NV. TEPEZZA is a trademark of Horizon Therapeutics plc.

1 American Cancer Society. "Multiple Myeloma Overview." Available at http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed June 2016.2 National Cancer Institute. "A Snapshot of Myeloma." Available at http://www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2016. 3 Globocan 2018. United States of America Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/840-united-states-of-america-fact-sheets.pdf.4 Globocan 2018. World Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed December 2018.5 American Cancer Society. "How is Multiple Myeloma Diagnosed?" http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 20166 DARZALEX Prescribing information, September 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf Last accessed September 20197 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed June 20208 DARZALEX FASPRO Prescribing information, May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf Last accessed May 20209 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.10 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.11 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.12 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974.

Company Announcement no. 38CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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August 20th, 2020

Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma compared to Darzalex and Empliciti which have 9 claims – Dexur

By daniellenierenberg

Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma compared to Darzalex and Empliciti which have 9 claims Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma compared to Darzalex and Empliciti which have 9 claims

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Dexurs analysis of Medicare claims data showed that on an average, Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma (MM) compared to Darzalex and Empliciti which have 9 claims per patient. The analysis was based on a sample of Medicare patients between Jan 2019 and Dec 2019, and looked at the J code usage of the drugs for the condition.The number of claims per patient data is a proxy for the number of injections / IV infusions / doses required by a patient. The study also tries to contrast the usage of these medications across three diagnosis categories- MM patients who have not achieved remission (C9000), MM patients in remission (C9001), and MM patients in relapse (C9002).

Multiple myeloma is a form of blood cancer that involves the neoplastic proliferation of plasma cells, a type of white blood cells formed within the bone marrow. While the earlier stages of the disease tend to be asymptomatic, patients may experience symptoms like bone pain, bleeding, frequent infections, and anemia with progression of the cancer. Although there is no cure for MM, a number of treatment options including chemotherapy, stem cell transplantation, radiation therapy, and targeted therapy, can help in managing the progression of the disease and relieving the symptoms.

The drugs considered under this study are targeted therapies approved for the treatment of adult patients with multiple myeloma, alone or in combination with other medication. Unlike chemotherapy, these drugs specifically target the cancer cells and the mechanisms that support their growth, promising better results and fewer adverse effects. Kyprolis (carfilzomib) and Velcade (bortezomib) are proteasome inhibitors that can trigger apoptosis in cancer cells by blocking the action of proteasome, an enzyme complex that is critical in the regulation of cell-cycle. Darzalex (daratumumab) and Empliciti (elotuzumab) are monoclonal antibodies that enable the immune system to identify and kill cancer cells by targeting specific proteins on the cell surface.

The average usage of drug per patient was seen to be highest among MM patients who had not achieved remission, and least among MM patients in remission. An exception to this trend was Kyprolis, which had similar usage among patients in remission and patients in relapse, with the former having a marginally higher number of claims per patient.

Amgens Kyprolis had an average of 15.9 claims per patient in a year. The proteasome inhibitor indicated for the treatment of patients with relapsed/refractory MM, is used as a monotherapy, or as a combination therapy along with dexamethasone, or lenalidomide and dexamethasone.

Velcade, manufactured by Millennium Pharmaceuticals/Takeda Oncology in the U.S, had an average of 13.8 claims per patient in a year. It was noted to have the largest share of claims among the drugs, across the three diagnosis categories for multiple myeloma. Approved for the treatment of newly diagnosed and relapsed/refractory myeloma, the drug is used alone or as a part of combination therapies.

Darzalex, a CD38-directed cytolytic antibody by Janssen Biotech, had an average of 9.9 claims per patient in a year for MM. It is indicated for the treatment of MM as a monotherapy or in combination with other drugs including lenalidomide, dexamethasone, and bortezomib.

Bristol-Myers Squibbs Empliciti had an average of 9.3 claims per patient. It is a SLAMF7-directed immunostimulatory antibody approved for the treatment of MM in combination with lenalidomide and dexamethasone, or pomalidomide and dexamethasone

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Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma compared to Darzalex and Empliciti which have 9 claims - Dexur

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August 20th, 2020

After Several Months of Providing Requested Information About Manufacturing and Safety of Leronlimab, U.K.’s MHRA Accepts CytoDyn’s Request to Enroll…

By daniellenierenberg

Patient enrollment to commence immediately

VANCOUVER, Washington, Aug. 20, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Clinical Trials Unit of the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government authorized the Company to enroll for its ongoing Phase 3 COVID-19 trial for severe-to-critical patients in the United Kingdom. The MHRAs decision follows several months of its review of CytoDyns manufacturing processes and leronlimabs safety profile.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We are very pleased with the MHRAs confidence in leronlimab to initiate enrollment of patients in the U.K. for our current CD12 protocol. CytoDyn recently requested fast track approval from the MHRA for its completed Phase 2 COVID-19 trial for the mild-to-moderate population, with strong efficacy and safety data. We believe leronlimab has multiple opportunities for several clinical indications and we are very optimistic about our future based upon how far we have advanced this drug in about 5 years. In addition, we plan to file a BLA for HIV in the U.K. within the next 4 weeks.

About Coronavirus Disease 2019CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. Enrollment continues in its Phase 3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 is believed to typically transmit person-to-person through respiratory droplets. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140)The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA has agreed to provide written responses to the Companys questions concerning its recent Biologics License Application by September 4, 2020, in lieu of a Type A teleconference meeting for this HIV combination therapy.

CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Michael MulhollandOffice: 360.980.8524, ext. 102Mobile: 503.341.3514mmulholland@cytodyn.com

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After Several Months of Providing Requested Information About Manufacturing and Safety of Leronlimab, U.K.'s MHRA Accepts CytoDyn's Request to Enroll...

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August 20th, 2020

Induced Pluripotent Stem Cells Market Size Is Anticipated To Reach US$ 17200 Mn at a CAGR of 7% By 2026, Owing to Increasing Number of Product…

By daniellenierenberg

The healthcare industry has been focusing on excessive research and development in the last couple of decades to ensure that the need to address issues related to the availability of drugs and treatments for certain chronic diseases is effectively met. Healthcare researchers and scientists at the Li Ka Shing Faculty of Medicine of the Hong Kong University have successfully demonstrated the utilization of human induced pluripotent stem cells or hiPSCs from the skin cells of the patient for testing therapeutic drugs.

The success of this research suggests that scientists have crossed one more hurdle towards using stem cells in precision medicine for the treatment of patients suffering from sporadic hereditary diseases. iPSCs are the new generation approach towards the prevention and treatment of diseases that takes into account patients on an individual basis considering their genetic makeup, lifestyle, and environment. Along with the capacity to transform into different body cell types and same genetic composition of the donors, hiPSCs have surfaced as a promising cell source to screen and test drugs.

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In the present research, hiPSC was synthesized from patients suffering from a rare form of hereditary cardiomyopathy owing to the mutations in Lamin A/C related cardiomyopathy in their distinct families. The affected individuals suffer from sudden death, stroke, and heart failure at a very young age. As on date, there is no exact treatment available for this condition.

This team in Hong Kong tested a drug named PTC124 to suppress specific genetic mutations in other genetic diseases into the iPSC transformed heart muscle cells. While this technology is being considered as a breakthrough in clinical stem cell research, the team at Hong Kong University is collaborating with drug companies regarding its clinical application.

The unique properties of iPS cells provides extensive potential to several biopharmaceutical applications. iPSCs are also used in toxicology testing, high throughput, disease modeling, and target identification. This type of stem cell has the potential to transform drug discovery by offering physiologically relevant cells for tool discovery, compound identification, and target validation.

A new report by Persistence Market Research (PMR) states that the globalinduced pluripotent stem or iPS cell marketis expected to witness a strong CAGR of 7.0% from 2018 to 2026. In 2017, the market was worth US$ 1,254.0 Mn and is expected to reach US$ 2,299.5 Mn by the end of the forecast period in 2026.

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Customization to be the Key Focus of Market Players

Due to the evolving needs of the research community, the demand for specialized cell lines have increased to a certain point where most vendors offering these products cannot depend solely on sales from catalog products. The quality of the products and lead time can determine the choices while requesting custom solutions at the same time. Companies usually focus on establishing a strong distribution network for enabling products to reach customers from the manufacturing units in a short time period.

Entry of Multiple Small Players to be Witnessed in the Coming Years

Several leading players have their presence in the global market; however, many specialized products and services are provided by small and regional vendors. By targeting their marketing strategies towards research institutes and small biotechnology companies, these new players have swiftly established their presence in the market.

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Persistence Market Research (PMR) is a third-platform research firm. Our research model is a unique collaboration of data analytics andmarket research methodologyto help businesses achieve optimal performance.

To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

Our client success stories feature a range of clients from Fortune 500 companies to fast-growing startups. PMRs collaborative environment is committed to building industry-specific solutions by transforming data from multiple streams into a strategic asset.

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Induced Pluripotent Stem Cells Market Size Is Anticipated To Reach US$ 17200 Mn at a CAGR of 7% By 2026, Owing to Increasing Number of Product...

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August 20th, 2020

Steadman Philippon Research Institute (SPRI) Receives Multi-Million-Dollar Matching Grant from the National Institutes of Health – GlobeNewswire

By daniellenierenberg

The trial is entitled,The Use of Senolytic and Anti-Fibrotic Agents to Improve the Beneficial Effect of Bone Marrow Stem Cells for Osteoarthritis. Huard explains in laypersons terms:

For further information or other inquiries about The Steadman Clinic or Steadman Philippon Research Institute, contact Lynda Sampson, Vice President of External Affairs (lsampson@sprivail.org).

Link to current SPRI clinical trials - https://www.sprivail.org/about-us/clinical-trials

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August 20th, 2020

Exosome Therapeutic Market 2020-2026 is Growing So Rapidly || Leading Players THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United…

By daniellenierenberg

This Exosome Therapeutic Market report comprises of the most recent market information with which companies can have in depth analysis of industry and future trends. By identifying the marketing strategies of rivals, businesses can set up innovative ideas and striking sales targets which ultimately make them achieve competitive advantage over its competitors. Because businesses can achieve great benefits with the different segments covered in the business document, every bit of market that can be included here is touched carefully. This report provides statistics on the current state of the industry as a helpful source of assistance and direction for companies and investors interested in this market.

This is the most relevant, unique, and creditable global business document which has been brought to valuable customers and clients depending upon their specific business needs. The Exosome Therapeutic Marketreport also displays important product developments and tracks recent acquisitions, mergers and research in the industry by the major players. Moreover, all the stats, data, facts and figures collected to prepare this market report are obtained from the trustworthy sources such as websites, journals, merges, newspapers and other authentic sources. Exosome Therapeutic Marketanalysis report also includes CAGR value fluctuations with respect to rise or fall for the certain forecast period.

Exosome therapeutic marketis expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

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Exosomes are used to transfer RNA, DNA, and proteins to other cells in the body by making alteration in the function of the target cells. Increasing research activities in exosome therapeutic is augmenting the market growth as demand for exosome therapeutic has increased among healthcare professionals.

Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market. Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.

This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for anAnalyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.

Competitive Landscape and Exosome Therapeutic Market Share Analysis

Global exosome therapeutic market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, concept cars, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companys focus related to global exosome therapeutic market.

The major players covered in the report are evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global. Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Many joint ventures and developments are also initiated by the companies worldwide which are also accelerating the global exosome therapeutic market.

For instance,

Partnership, joint ventures and other strategies enhances the company market share with increased coverage and presence. It also provides the benefit for organisation to improve their offering for exosome therapeutics through expanded model range.

Global Exosome Therapeutic Market Scope and Market Size

Global exosome therapeutic market is segmented of the basis of type, source, therapy, transporting capacity, application, route of administration and end user. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Based on type, the market is segmented into natural exosomes and hybrid exosomes. Natural exosomes are dominating in the market because natural exosomes are used in various biological and pathological processes as well as natural exosomes has many advantages such as good biocompatibility and reduced clearance rate compare than hybrid exosomes.

Exosome is an extracellular vesicle which is released from cells, particularly from stem cells. Exosome functions as vehicle for particular proteins and genetic information and other cells. Exosome plays a vital role in the rejuvenation and communication of all the cells in our body while not themselves being cells at all. Research has projected that communication between cells is significant in maintenance of healthy cellular terrain. Chronic disease, age, genetic disorders and environmental factors can affect stem cells communication with other cells and can lead to distribution in the healing process. The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.

Rising demand of exosome therapeutic across the globe as exosome therapeutic is expected to be one of the most prominent therapies for autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases treatment, according to clinical researches exosomes help to processes regulation within the body during treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases. This factor has increased the research activities in exosome therapeutic development around the world for exosome therapeutic. Hence, this factor is leading the clinician and researches to shift towards exosome therapeutic. In the current scenario the exosome therapeutic are highly used in treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases and as anti-aging therapy as it Exosomes has proliferation of fibroblast cells which is significant in maintenance of skin elasticity and strength.

TABLE OF CONTENTS

PART 01: EXECUTIVE SUMMARY

PART 02: SCOPE OF THE REPORT

PART 03: RESEARCH METHODOLOGY

PART 04: MARKET LANDSCAPE

Market ecosystem Market characteristics Market segmentation analysis

PART 05: PIPELINE ANALYSIS

Pipeline analysis

PART 06: MARKET SIZING

Market definition Market sizing Market size and forecast

PART 07: FIVE FORCES ANALYSIS

Bargaining power of buyers Bargaining power of suppliers Threat of new entrants Threat of substitutes Threat of rivalry Market condition

PART 08: MARKET SEGMENTATION

Segmentation Comparison Market opportunity

PART 09: CUSTOMER LANDSCAPE

PART 10: REGIONAL LANDSCAPE

Geographical segmentation Regional comparison North America South America Europe MEA APAC Market opportunity

PART 11: DECISION FRAMEWORK

PART 12: DRIVERS AND CHALLENGES

Market drivers Market challenges

PART 13: MARKET TRENDS

PART 14: VENDOR LANDSCAPE

Overview Landscape disruption

PART 15: VENDOR ANALYSIS

Vendors covered Vendor classification Market positioning of vendors

PART 16: APPENDIX

List of abbreviations

For More Insights Get FREE Detailed TOC @https://www.databridgemarketresearch.com/toc/?dbmr=global-exosome-therapeutic-market&pm

Exosome therapeutic Market Country Level Analysis

The global exosome therapeutic market is analysed and market size information is provided by country by type, source, therapy, transporting capacity, application, route of administration and end user as referenced above.

The countries covered in the exosome therapeutic market report are U.S. and Mexico in North America, Turkey in Europe, South Korea, Australia, Hong Kong in the Asia-Pacific, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua, Uruguay as part of Latin America.

Country Level Analysis, By Type

North America dominates the exosome therapeutic market as the U.S. is leader in exosome therapeutic manufacturing as well as research activities required for exosome therapeutics. At present time Stem Cells Group holding shares around 60.00%. In addition global exosomes therapeutics manufacturers like EXOCOBIO, evox THERAPEUTICS and others are intensifying their efforts in China. The Europe region is expected to grow with the highest growth rate in the forecast period of 2019 to 2026 because of increasing research activities in exosome therapeutic by population.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

Research objectives

Huge Investment by Automakers for Exosome Therapeutics and New Technology Penetration

Global exosome therapeutic market also provides you with detailed market analysis for every country growth in pharma industry with exosome therapeutic sales, impact of technological development in exosome therapeutic and changes in regulatory scenarios with their support for the exosome therapeutic market. The data is available for historic period 2010 to 2017.

About Data Bridge Market Research:

An absolute way to forecast what future holds is to comprehend the trend today!Data Bridge set forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process.

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August 20th, 2020

On the move at the OneAZ, Spencer Fane, UArizona – AZ Big Media

By daniellenierenberg

OneAZ Credit Union names Ken Bauer SVP

OneAZ Credit Union announced Ken Bauer as senior vice president, Credit Administration.

Bauer oversees OneAZs mortgage, business and commercial banking teams, emphasizing efficiency and excellence to help the organization succeed. He joined OneAZ Credit Union in 2020, bringing 20 years of experience in commercial banking with local and national banks and credit unions.

Established in 1951, OneAZ Credit Union is owned by its members and serves Arizona with 20 locations and more than 140,000 members

Spencer Fane LLP announced Kelly Mooney has joined the firm as of counsel. She will be part of the Tax, Trusts, & Estates practice group and work out of the firms Phoenix office.

Mooneys practice focuses on handling complex matters related to federal taxation, working with attorneys in other practice groups to structure transactions that comply with federal tax law, offer tax relief when applicable, and provide tax-efficient results for her clients. She regularly assists clients with tax planning and analysis for partnerships, LLCs, and corporations; real estate joint ventures organized as LLCs and general and limited partnerships; and individuals.

Spencer Fane understands that tax issues impact virtually every aspect of business, investment, and personal wealth management, said Andy Federhar, Spencer Fane office managing partner in Phoenix. We understand our clients needs to assist them with finding the best solutions to favorably handle their tax liability, and Kellys experience in handling these matters through collaborative analysis fits well with our firms approach to client service.

Mooney has an accomplished track record of representing clients before the Internal Revenue Service and other taxing authorities on ruling requests, civil controversy cases, and collection matters. Her work has included successfully negotiating the settlement of several complex and multiyear IRS examinations and cases involving the imposition of trust fund penalties and contested claims for refund.

The University of Arizona College of Nursing has announced key new appointments, promotions, honors, awards and other notable items in recent weeks, including:

After a national search, the UArizona College of Nursing has named Kelley Wilson, DNP, MSN, CMSRN, as the new program director of the colleges Master of Science for Entry to the Profession of Nursing (MEPN) program. Dr. Wilson joins the college from Georgetown Universitys School of Nursing and Health Studies, where she had been serving as program director for the schools Bachelor of Science in Nursing program. She assumed her new role on July 13.

Dr. Wilson brings a wealth of experience in teaching and developing courses and academic programs, said Connie Miller, DNP, RNC-OB, CNE, clinical associate professor and chair, General Nursing and Health Education Division. She has solid experience in mentoring and leading teams, in addition to proven track record of service and scholarship. We look forward to welcoming her to our MEPN team.

Aleeca Bell, PhD, RN, CNM, joined the College of Nursing in mid-July. Dr. Bell most recently was an associate professor at the University of Illinois at Chicago (UIC), College of Nursing, Department of Women Children and Family Health Science. At UIC, she also earned her masters degree in nursing in midwifery in 1998, practiced as a certified nurse midwife, and earned a doctorate in nursing in 2009. In addition, she was a postdoctoral fellow there from 2009-11.

Dr. Bells research in translational, multidisciplinary and biobehavioral clinical studies focuses on the intersection of perinatal mother-infant health outcomes and the underlying oxytocin system. Oxytocin is a hormone that acts on organs in womens bodies and as a chemical messenger in the brain, controlling key aspects of the reproductive system, including childbirth, lactation and some behavior. This includes womens childbirth experience, intrapartum medical interventions, the endogenous oxytocin system (hormonal, genetic and epigenetic), maternal postnatal mood/anxiety and caregiving attitudes, newborn behaviors and mother-infant interaction. Learn more.

Tracy E. Crane, PhD, a College of Nursing assistant professor, has focused much of her career on cancer survivorship. She is co-director of the Behavioral Measurements and Interventions Shared Resource at the UArizona Cancer Center and a member of the UArizona Data Science Institute. Shes also co-chair of the cancer prevention and control behavioral science working group for NRG Oncology, a research non-profit led by faculty at Columbia University, NYU Langone Health, the University of Michigan and UArizona.

With a research focus on improving adherence to healthy lifestyle behaviors in cancer survivors and their informal caregivers, Dr. Crane has developed interventions geared toward extending lifespans of post-treatment ovarian cancer survivors and telephone counseling to improve diet and physical activity in Latina cancer patients. In early 2020, Dr. Crane extended her expertise across the Atlantic when she helped researchers at Gustave Roussy, Europes largest cancer center, fine-tune a new cancer study, Motivating to Exercise and Diet, and Educating to Healthy Behaviors After Breast Cancer (MEDEA).

In keeping with Dr. Cranes previous research, MEDEA aims to compare the effect of a personalized telephone-based health education weight-loss program based on motivational coaching, exercise and diet, compared with a standard health educational program control on fatigue of overweight or obese breast cancer patients. Learn more.

According to new research from College of Nursing Associate Professor Ruth Taylor-Piliae, PhD, RN, FAHA, tai chi can be beneficial to the psychological well-being for adults suffering from cardiovascular disease. Published in June in the European Journal of Cardiovascular Nursing, Dr. Taylor-Piliaes review and meta-analysis of more than a dozen studies on the topic found that the exercise eased stress, anxiety, depression and psychological distress for those who practiced the mind-body exercise that emphasizes concentration on posture, relaxation and breathing, using a soothing series of set movements. Go to the UArizona Health Sciences Connect website for a video on her research. Learn more.

Three cardiologists recently joined the University of Arizona Sarver Heart Center. Arka Chatterjee, MD, Talal Moukabary, MD, and Madhan Sundaram, MBBS, joined the faculty of the UArizona College of Medicine Tucson and are now seeing patients at Banner University Medical Center Tucson.

With the addition of Drs. Chatterjee, Moukabary and Sundaram we continue the rapid growth in cardiovascular medicine at the University of Arizona and Banner UMC Tucson and we enhance our ability to provide highly personalized and expert care in the most advanced cardiology procedures to our patients, said Nancy K. Sweitzer, MD, PhD, director of the UArizona Sarver Heart Center, professor of medicine and chief of the Division of Cardiology in the Department of Medicine at the college.

These three physicians not only bring experience in electrophysiology, coronary and peripheral interventions and minimally invasive valve replacement, but they will expand the research offerings of the Sarver Heart Center in important areas of cardiology. This will allow us to bring the latest advances in heart disease treatment to the people of Southern Arizona, added Dr. Sweitzer.

Drs. Chatterjee and Moukabary are associate professors and Dr. Sundaram is an assistant professor of medicine.

In addition, Dr. Chatterjee is associate director of the Structural Heart Program at Banner UMC Tucson. He is board certified in interventional cardiology, cardiovascular disease, internal medicine and echocardiography. Dr. Chatterjee is experienced in transcatheter therapies for valvular disease and other congenital/structural heart defects. He has completed more than 200 transcatheter aortic valve replacement (TAVR) procedures. He finds the best part of working in the structural heart team is the synergy that occurs when a multidisciplinary team of expert providers works together to identify the ideal treatment for each patients unique case. Dr. Chatterjees research interests include outcomes research after coronary, structural and adult congenital interventions, and advances in structural and device therapies for heart disease.

Dr. Moukabary is a cardiac electrophysiologist (a cardiologist specializing in heart rhythm disorders or arrhythmias). He is an expert in computer modeling of cardiac arrhythmia, imaging in the cardiac electrophysiology lab, cell-based arrhythmia therapy and clinical cardiac electrophysiology. He is board certified in clinical cardiac electrophysiology and internal medicine. Dr. Moukabarys research interests include use of stem cell and iPS (induced pluripotent stem) cell therapies for heart rhythm disorders.

Dr. Sundaram is director of the Banner UMC Tucson Cardiac Catheterization Lab and Endovascular Services. He is board certified in interventional cardiology, cardiovascular disease, echocardiography and internal medicine. His clinical interests include complex coronary interventions, chronic total occlusions, endovascular peripheral interventions, interventions for acute pulmonary embolism and structural heart disease interventions. His research interests include cardiac interventions in older adults and clinical trials in coronary artery disease, peripheral artery disease and pulmonary embolism.

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August 20th, 2020

Scientists grow the first functioning mini human heart model – MSUToday

By daniellenierenberg

Michigan State University researchers have created for the first time a miniature human heart model in the laboratory, complete with all primary heart cell types and a functioning structure of chambers and vascular tissue.

Aitor Aguirre, assistant professor of biomedical engineering at MSUs Institute for Quantitative Health Science and Engineering.

These minihearts constitute incredibly powerful models in which to study all kinds of cardiac disorders with a degree of precision unseen before, said Aitor Aguirre, the studys senior author and assistant professor of biomedical engineering at MSUs Institute for Quantitative Health Science and Engineering.

This study, Generation of Heart Organoids Modeling Early Human Cardiac Development Under Defined Conditions, appears on the bioRxiv preprint server and was funded by grants from the American Heart Association and the National Institutes of Health. In the United States, heart disease is the No. 1 cause of death.

The human heart organoids, or hHOs for short, were created by way of a novel stem cell framework that mimics the embryonic and fetal developmental environments.

Organoids meaning resembling an organ are self-assembling 3D cell constructs that recapitulate organ properties and structure to a significant extent, said Yonatan Israeli, a graduate student in the Aguirre Lab and first author of the study.

The innovation deploys a bioengineering process that uses induced pluripotent stem cells adult cells from a patient to trigger embryonic-like heart development in a dish generating a functional mini heart after a few weeks. The stem cells are obtained from consenting adults and therefore free of ethical concerns.

This process allows the stem cells to develop, basically as they would in an embryo, into the various cell types and structures present in the heart, Aguirre said. We give the cells the instructions and they know what they have to do when all the appropriate conditions are met.

Because the organoids followed the natural cardiac embryonic development process, the researchers studied, in real time, the natural growth of an actual fetal human heart.

This technology allows for the creation of numerous hHOs simultaneously with relative ease, contrasting with existing tissue engineering approaches that are expensive, labor intensive and not readily scalable.

One of the primary issues facing the study of fetal heart development and congenital heart defects is access to a developing heart. Researchers have been confined to the use of mammalian models, donated fetal remains and in vitro cell research to approximate function and development.

Now we can have the best of both worlds, a precise human model to study these diseases a tiny human heart without using fetal material or violating ethical principles. This constitutes a great step forward, Aguirre said.

Whats next? For Aguirre, the process is twofold. First, the heart organoid represents an unprecedented look into the nuts and bolts of how a fetal heart develops.

In the lab, we are currently using heart organoids to model congenital heart disease the most common birth defect in humans affecting nearly 1% of the newborn population, Aguirre said. With our heart organoids, we can study the origin of congenital heart disease and find ways to stop it.

And second, while the hHO is complex, it is far from perfect. For the team, improving the final organoid is another key avenue of future research. The organoids are small models of the fetal heart with representative functional and structural features, Israeli said. They are, however, not as perfect as a human heart yet. That is something we are working toward.

Aguirre and team are excited about the wide-ranging applicability of these miniature hearts. They enable an unprecedented ability to study many other cardiovascular-related diseases from chemotherapy-induced cardiotoxicity to the effect of diabetes, during pregnancy, on the developing fetal heart.

Other researchers involved in this study were Aaron Wasserman, Mitchell Gabalski and Kristen Ball at MSU; and Chao Zhou, Jinyon Zhou and Guangming Ni at Washington University in St. Louis.

(Note for media: Please include a link to the original paper in online coverage: https://www.biorxiv.org/content/10.1101/2020.06.25.171611v2)

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August 20th, 2020

Stem Cell Therapy Market Segmentation, Assessment and Growth Opportunities by Forecast 2025 – Scientect

By daniellenierenberg

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

The regional analysis covers:

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Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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TMR Research is a premier provider of customized market research and consulting services to business entities keen on succeeding in todays supercharged economic climate. Armed with an experienced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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August 20th, 2020

ASU engineers get to the heart of organs-on-a-chip – ASU Now

By daniellenierenberg

August 17, 2020

Denver is known for its relatively mild climate and its four distinct seasons. Its also known for its temperature fluctuations over the course of a day or even hours. But what does that mean for the citys residents and for that matter, the rest of the inhabitants of the continental United States when it comes to temperature extremes?

Thats what Ashley Broadbentwanted to know. Specifically, he wanted to know how populations throughout the United States will experience heat and cold during the 21st century.

So, Broadbent, an assistant research professor in Arizona State Universitys School of Geographical Sciences and Urban Planning, used state-of-the-art modeling tools to analyze how three key variables would affect human exposure to extreme temperatures from the beginning of this century to its end.

He and his collaborator Matei Georgescu, an associate professor in the School of Geographical Sciences and Urban Planning, concentrated on the following three key factors: climate change brought about by greenhouse gas emissions, urban development-induced impacts arising from the growth of cities, and population change in individual cities.

The paper, "The motley drivers of heat and cold exposure in 21st century U.S. cities," was published onlineAug. 17 in the Proceedings of the National Academy of Sciences. It is the first study of its kind to consider population-weighted heat and cold exposure that directly and simultaneously account for greenhouse gas and urban development-induced warming.

Graphic by Alex Davis/ASU Media Relations and Strategic Communications

To describe how these three variables would affect temperatures, and in turn populations, Broadbent, Georgescu and co-author Eric Scott Krayenhoff, assistant professor at the University of Guelph, Ontario, in Canada, used a metric they dubbed person-hours, to describe humans exposure to extreme heat and cold.

Its an intuitive metric, Broadbent said. For example, when one person is exposed to one hour of an extreme temperature, that exposure equals one person-hour of exposure. Likewise, if 10 people are exposed to 10 hours of an extreme temperature, that exposure equals 100 person-hours.

I think this definition is more representative of what people experience, which is what this study is about versus a study that simply communicates temperature changes without any human element attached to it, Broadbent said.

Overall, the researchers found that the average annual heat exposure at the start of this century in the United States was about 5.2 billion person-hours. Assuming a worst-case scenario of peak global warming, population growth and urban development, the annual heat exposure would rise to 150 billion person-hours by the end of the century, a nearly 30-fold increase.

The combined effect of these three drivers will substantially increase the average heat exposure across the United States, but heat exposure is not projected to increase uniformly in all cities across the U.S., Broadbent said. There will be hot spots where heat exposure grows sharply.

To that end, the researchers defined heat thresholds based on local city definitions, something previous studies have not done. Instead, prior studies have used fixed-temperature thresholds that may be inappropriate for some cities. Afterall, a 90-degree day in Phoenix feels much different than a 90-degree day in New York City, given relative humidity differences.

Its well-known that cities have locally defined thresholds where heat and cold cause mortality and morbidity, Broadbent explained. In other words, people die at different temperatures in different cities because what is extreme in one city may be normal in another.

Importantly, areas of the United States where human exposure would increase the most is where climate change and population increase in tandem. Meanwhile, urban development has a smaller, yet not negligible effect.

According to the results of the study, the largest absolute changes in population heat exposure are projected to occur in major U.S. metropolitan regions, such as New York, Los Angeles and Atlanta.

The study also finds the largest relativechanges in person-hours related to heat exposure are projected to occur in rapidly growing cities located in the Sun Belt, including Austin, Texas; Orlando, Florida; and Atlanta.

The increase in exposure is quite large if you look at it relative to the start of the century, Broadbent said. Some cities across the Sun Belt, according to our projections, will have 90 times the number of person-hours of heat exposure. For example, cities in Texas that see substantial population growth and strong greenhouse gas-induced climate warming could be markedly affected.

One way to prepare for increased heat exposure is to reduce greenhouse gas emissions on a global scale, which would reduce the number of hours people are exposed to extreme temperatures. Other options include localized infrastructure adaptation that provides buffering effects against rising temperatures such as planting trees, providing shade and cooling areas and constructing buildings using materials that absorb less heat.

Although the average temperature in the United States will be warmer in the future, the study finds that cold exposure will increase slightly compared with the start of the century, primarily because of population growth. While there is a generaldecreasein the number of projected extreme cold events by the end of this century, the number of individuals exposed to extreme cold is projected toincrease,as population growth means that the total number of person-hours of cold exposure will go up, Broadbent said.

Cold is currently more of a national health problem than heat, but our results suggest that by the end of the century heat exposure may become a larger health problem than cold exposure, Broadbent said. However, cold exposure will not disappear completely as the climate warms. In fact, according to one of the teams simulations, Denver is projected to have more extreme cold at the end of the century compared with the beginning, according to the study.

Thats the interesting thing about climate change. We know the average temperature is going to increase, said Broadbent. But we know less about how the extremes are going to change, and often the extremes are the most important part of our daily lives.

There are several takeaway messages from this work, but one of the central ones concerns the future resiliency of our cities, Georgescu said.

The successful steps taken will require holistic thinking that embraces contributions from urban planners, engineers, social scientists and climate scientists with a long-range vision of how we want our cities to be.

"We therefore call on cities to start asking some very foundational questions regarding the projected exposure of their constituents to future environmental change," Georgescu said. "Is the work of the urban climate modeling community being integrated into their environmental adaptation plans? If so, how, and if not, why not?

This work was funded by the National Science Foundation.

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August 20th, 2020

Worldwide Dilated Cardiomyopathy (DCM) Market Insights, Epidemiology and Forecast – 2030 – ResearchAndMarkets.com – Business Wire

By daniellenierenberg

DUBLIN--(BUSINESS WIRE)--The "Dilated Cardiomyopathy (DCM) - Market Insights, Epidemiology and Market Forecast - 2030" drug pipelines report has been added to ResearchAndMarkets.com's offering.

This report delivers an in-depth understanding of the Dilated Cardiomyopathy, historical and forecasted epidemiology as well as the Dilated Cardiomyopathy market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), and Japan.

The Dilated Cardiomyopathy market report provides current treatment practices, emerging drugs, Dilated Cardiomyopathy market share of the individual therapies, current and forecasted Dilated Cardiomyopathy market size from 2017 to 2030 segmented by seven major markets. The report also covers current Dilated Cardiomyopathy treatment practice/algorithm, market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses underlying potential of the market.

Epidemiology

The Dilated Cardiomyopathy epidemiology division provides the insights about historical and current Dilated Cardiomyopathy patient pool and forecasted trend for each seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

The disease epidemiology covered in the report provides historical as well as forecasted Dilated Cardiomyopathy epidemiology segmented as [Total Prevalent Population of Dilated Cardiomyopathy, Total Diagnosed Population of Dilated Cardiomyopathy, Familial and non-familial cases of Dilated Cardiomyopathy, Gender-Specific Cases of Dilated Cardiomyopathy, and Total Treated Cases of Dilated Cardiomyopathy] scenario of Dilated Cardiomyopathy in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan from 2017 to 2030.

Key Findings

Drug Chapters

Drug chapter segment of the Dilated Cardiomyopathy report encloses the detailed analysis of Dilated Cardiomyopathy marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Dilated Cardiomyopathy clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Approved Drug

Corlanor (ivabradine): Amgen

Corlanor (ivabradine) is a hyperpolarization-activated cyclic nucleotide-gated channel blocker that reduces the spontaneous pacemaker activity of the cardiac sinus node by selectively inhibiting the If current, resulting in heart rate reduction with no effect on ventricular repolarization and no effects on myocardial contractility.

The US FDA approval of Corlanor (ivabradine) for the treatment of stable symptomatic heart failure (HF) due to dilated cardiomyopathy in pediatric patients aged 6 months to 18 years was based on a randomized, double-blind, placebo-controlled trial in 116 patients aged 6 months to less than 18 years with symptomatic DCM in sinus rhythm, NYHA/Ross class II to IV HF, and left ventricular ejection fraction 45%. The primary endpoint of the study was 20% reduction in resting heart rate from baseline without bradycardia or symptoms after an initial titration period.

Emerging Drugs

PF-07265803/ARRY-371797/ARRY-797: Pfizer

ARRY-371797 which is also known as ARRY-797 is an oral, p38 mitogen activated protein kinase (MAPK) inhibitor discovered by Array scientists. Compared to other p38 MAPK inhibitors ARRY-797 has unique and differentiated properties: it is highly selective, retains exceptional potency in whole blood and possesses a favorable pharmacokinetic profile. It is currently under phase III trial for the treatment of patients affected with dilated cardiomyopathy due to a Lamin A/C gene mutation. In the year 2019, Pfizer completed the acquisition of Array Biopharma to expand its pipeline and currently this drug is in phase III pipeline drugs of Pfizer with name PF-07265803 for the treatment of patients affected by dilated cardiomyopathy.

Ixmyelocel-T: Vericel

Ixmyelocel-T is an investigational autologous expanded multicellular therapy manufactured from the patient's own bone marrow using Vericel's proprietary, highly automated, fully closed cell-processing system. This process selectively expands the population of mesenchymal stromal cells and alternatively activated macrophages, which are responsible for production of anti-inflammatory and pro-angiogenic factors known to be important for repair of damaged tissue. Ixmyelocel-T has been designated as an orphan drug by the U.S. Food and Drug Administration for use in the treatment of DCM. However, currently the development of this drug is at halt because as per the recent news the company do not have current plans to initiate or fund a phase III trial for this drug at their own.

BC007: Berlin Cures GmbH

BC007 is a DNA aptamer-based compound that binds to and eliminates pathogenic autoantibodies directed against the beta-1 adrenoceptor, a receptor belonging to the large family of cell surface receptors known as G-protein coupled receptors that regulate the heart's rate and contraction strength.

Ifetroban: Cumberland Pharmaceuticals

Ifetroban is a potent and selective inhibitor of the thromboxane receptor (TPr), preventing fibrosis and an inflammatory response. It was initially developed by Bristol-Myers Squibb as an anti-platelet agent to prevent blood clots (blood thrombus), and was acquired by Cumberland in 2011. It is believed that this drug molecule is able to stop important molecular signals that mediate inflammation and fibrosis (tissue scaring) mechanisms in the heart, triggered by the loss of dystrophin protein.

Danicamtiv/MYK-491: MyoKardia

MYK-491 is an orally-administered small molecule designed to increase the number of myosin-actin cross-bridges formed during cardiac muscle contraction while having minimal impact on diastolic function. In the heart, myosin is the motor protein that binds to actin to generate the force and movement of contraction. In patients with dilated cardiomyopathy and systolic heart failure, in which the left ventricle of the heart is too distended and weak to adequately pump blood to meet the body's needs, MYK-491 is intended to increase myosin-actin engagement, thereby targeting the biomechanical defects underlying disease and improving cardiac contractility.

CAP-1002: Capricor Therapeutics

CAP-1002, Capricor's lead product candidate, is a proprietary allogeneic adult stem cell therapy for the treatment of heart disease. The product is derived from donor heart tissue. The cells are expanded in the laboratory using a specialized process and then introduced directly into a patient's heart via infusion into a coronary artery using standard cardiac catheterization techniques. CAP-1002 consists of allogeneic cardiosphere-derived cells, or CDCs, a unique population of cells that has been shown to exert potent immunomodulatory activity and alters the immune system's activity to encourage cellular regeneration.

Market Outlook

Besides treating any recognizable and reversible underlying causes, the management and treatment of DCM are in concordance with the standard heart failure guidelines. Currently, the treatment pattern of DCM is mainly dependent on pharmacological therapy, pacing therapy, surgical options, and Corlanor (ivabradine).

The pharmacological therapies consist of diuretics, inotropic agents, afterload reducing agents, beta-blockers, anticoagulation medications, anti-arrhythmia medications. The main diuretics that are prescribed for the treatment are furosemide, spironolactone, bumetanide, and metolazone. Common side effects of diuretics include dehydration and abnormalities in the blood chemistries particularly potassium loss. Inotopric agents that are prescribed for the treatment are digoxin, dobutamine, dopamine, epinephrine, norepinephrine, vasopressin, and milrinone. Some afterload reducing medications include angiotensin-converting enzyme inhibitors (ACE inhibitors) such as captopril, enalMay, lisinopril, monopril, angiotensin I blocker such as losartan. Losartan and milrinone are inotropic agents that also relax the arteries. Stronger anticoagulation drugs are warfarin, heparin, and enoxaparin; these drugs require careful monitoring with regular blood testing.

Angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARB) have shown benefit in the treatment of heart failure with reduced ejection fraction and are suggested for the patients affected with DCM. Aldosterone receptor blockade with spironolactone or eplerenone also is recommended in patients with New York Heart Association (NYHA) heart failure class II-IV and systolic dysfunction. Similarly, beta-blockade with carvedilol, bisoprolol, or long-acting metoprolol is recommended in all patients with heart failure with reduced ejection fraction without any contraindications. The addition of isosorbide dinitrate plus hydralazine also has shown to increase survival amongst those with advanced disease.

In some cases, beta-blockers allow an enlarged heart to become more normal in size. Common beta-blockers include carvedilol, metoprolol, propranolol, and atenolol. Side effects include dizziness, low heart rate, low blood pressure, and, in some cases, fluid retention, fatigue, impaired school performance, and depression. The choice of anticoagulation drugs depends on how likely it is that a blood clot will form. Less strong anticoagulation medications include aspirin and dipyridamole. Common anti-arrhythmia medications include amiodarone, procainamide, and lidocaine. Also, Corlanor (ivabradine) is an approved therapy for the treatment of 6 months to 18 years old patient affected by Dilated Cardiomyopathy.

Key Findings

According to the report, Dilated Cardiomyopathy market in the 7MM is expected to change in the study period 2017-2030. The total therapeutic market of Dilated Cardiomyopathy in seven major markets was found to be USD 244 million in 2017 which is expected to increase during the study period (2017-2030).

The United States Market Outlook

In 2017, the total market size of Dilated Cardiomyopathy therapies was estimated to be USD 142.9 million in the United States which is expected to increase in the study period (2017-2030).

EU5 Countries: Market Outlook

In 2017, the total market size of Dilated Cardiomyopathy therapies was found to be USD 74.4 million in the EU5 countries which is expected to increase in the study period (2017-2030).

Japan Market Outlook

The total market size of Dilated Cardiomyopathy therapies in Japan was found to be USD 27.1 million in 2017 which is also expected to increase during the study period (2017-2030).

Pipeline Development Activities

The drugs which are in pipeline include:

1. PF-07265803/ARRY-371797/ARRY-797: Pfizer

2. Ixmyelocel-T: Vericel

3. BC007: Berlin Cures GmbH

4. Ifetroban: Cumberland Pharmaceuticals

5. Danicamtiv/MYK-491: MyoKardia

6. CAP-1002: Capricor Therapeutics

Access and Reimbursement Scenario

The record published in United HealthCare Services, in the United States, stated that reimbursement is eligible for the CPT codes related to various genetic testing for cardiac disease. CPT code 81439 includes indications such as hereditary cardiomyopathy (e.g., hypertrophic cardiomyopathy, dilated cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy), genomic sequence analysis panel - must include sequencing of at least five cardiomyopathy-related genes (e.g., DSG2, MYBPC3, MYH7, PKP2, TTN). Moreover, cardiomyopathies that present primarily as neuromuscular disorders and related genetic testing are also covered in the Medical Policy.

KOL Views

To keep up with current market trends, we take KOL's and SME's opinion working in Dilated Cardiomyopathy domain through primary research to fill the data gaps and validates our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns and Dilated Cardiomyopathy market trend. This will support the clients in the introduction of potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

The publisher performs Competitive and Market Intelligence analysis of the Dilated Cardiomyopathy Market by using various Competitive Intelligence tools that includes - SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

Report Highlights

Companies Mentioned

For more information about this drug pipelines report visit https://www.researchandmarkets.com/r/qfjown

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August 20th, 2020

Placental Stem Cells (PSCS) Market 2020-2027 Reporting And Evaluation of Recent Industry Developments || Leading Players StemCyte India Therapeutics…

By daniellenierenberg

This Placental Stem Cells (PSCS) Market report is an outcome of persistent efforts lead by knowledgeable forecasters, innovative analysts and brilliant researchers who carries out detailed and diligent research on different markets, trends and emerging opportunities in the consecutive direction for the business needs. The report also estimates CAGR (compound annual growth rate) values along with its fluctuations for the definite forecast period. The report provides key measurements, status of the manufacturers and is a significant source of direction for the businesses and organizations. While generating this Placental Stem Cells (PSCS) Market research report, customer satisfaction is kept on the utmost priority.

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Placentalstem cells(PSCS) market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to growing at a CAGR of 10.25% in the above-mentioned forecast period. Increasing awareness regarding the benefits associates with the preservation of placental derived stem cells will boost the growth of the market.

The major players covered in theplacental stem cells (PSCS) marketreport areCBR Systems, Inc, Cordlife India, Cryo-Cell International, Inc., ESPERITE N.V., LifeCell International Pvt. Ltd., StemCyte India Therapeutics Pvt. Ltd, PerkinElmer Inc, Global Cord Blood Corporation., Smart Cells International Ltd., Vita 34, among other domestic and global players. Market share data is available for Global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately.DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

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Key Questions Answered in Global Placental Stem Cells (PSCS) Market Report

Market Analysis and Insights of Global Placental Stem Cells (PSCS) Market

Adoption of advances and novel technologies that will lead to the storage and preservation of stem cells, technological advancement in the field of biotechnology, introduction of hematopoietic stem cell transplantation system and growing number of diseases which will helps in accelerating the growth of the placental stem cells (PSCS) market in the forecast period of 2020-2027. Surging number of applications from emerging economies along with rising awareness among the people will further boost many opportunities that will led to the growth of the placental stem cells (PSCS) market in the above mentioned forecast period.

Increasing operation costs along with stringent regulatory framework will likely to hamper the growth of the placental stem cells (PSCS) market in the above mentioned forecast period. Social and ethical issues will be the biggest challenge in the growth of the market.

Thisplacental stem cells(PSCS) market report provides details of new recent developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on placental stem cells (PSCS) market contactData Bridge Market Researchfor anAnalyst Brief, our team will help you take an informed market decision to achieve market growth.

Global Placental Stem Cells (PSCS) Market Scope and Market Size

Placental stemcells(PSCS) market is segmented on the basis of service type and application. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Placental Stem Cells (PSCS) Market Country Level Analysis

Placental stemcells(PSCS) market is analysed and market size insights and trends are provided by country, service type and application as referenced above.

The countries covered in the placental stem cells (PSCS) market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America dominates the bone marrow-derived stem cells (BMSCS) market due to the increasing stem cell procedure along with preferences of private stem cell banking over public and surging network of stem cell banking services.

The country section of the placental stem cells (PSCS) market report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as consumption volumes, production sites and volumes, import export analysis, price trend analysis, cost of raw materials, down-stream and upstream value chain analysis are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Healthcare Infrastructure growth Installed base and New Technology Penetration

Placental stem cells (PSCS) market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipments, installed base of different kind of products for placental stem cells (PSCS) market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the placental stem cells (PSCS) market. The data is available for historic period 2010 to 2018.

Competitive Landscape and Placental Stem Cells (PSCS) Market Share Analysis

Placental stem cells (PSCS) market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies focus related to placental stem cells (PSCS) market.

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August 19th, 2020

Hamiltonian with Incurable Cancer is Helping Researchers Get One Step Closer to a Cure at the 3rd Annual Hamilton Multiple Myeloma March – The Bay…

By daniellenierenberg

In 2014, Clive Webb returned home from one of his regular judo training sessions a sport he has been avidly practising since he was 13 years old and started experiencing severe back pain. Initially he brushed it off, thinking he had pulled a muscle. When the pain persisted, Clive decided to make an appointment with his doctor who soon discovered that he had stress fractures in seven of his vertebrae. A few days later, Clive was diagnosed with multiple myeloma, a little-known and incurable cancer of the plasma cells. He was just 55 years old.

The diagnosis hit close to home. I figured it out prior to being told what was wrong because my father had been diagnosed with myeloma in 1996, and he had had very similar symptoms, Clive recalled.

In May 2014, Clive underwent extensive chemotherapy to prepare for a stem cell transplant. In October of the same year, he was thrilled to find out that the procedure was a success and that he was in remission. Since then, Clive has been responding well to a drug maintenance regime. There have been so many amazing advances in treatment since Clives fathers passing, explained Clives wife, Yvette. Were hopeful for what the future holds.

Now with his condition relatively stable, Clive is extremely grateful to be alive. He has resumed physiotherapy in the gym, gardening, and taking walks with Yvette. He credits this to the life-saving treatments that he has access to, the outstanding care he gets from health professionals, and to the love and support of his wife. The couple is now eager to do what they can to help others living with the disease.

After attending the Hamilton Multiple Myeloma March last year, they joined the Hamilton and District Multiple Myeloma Network support group. The couple is more intent than ever to raise as much awareness and funds for myeloma as they can. As such, they will once again be participating in the 3rd annual Hamilton Multiple Myeloma March with their team, the Myeloma Movers, on Saturday, September 12, at 9 am, at the Edgewater Pavilion. The in-person, live event will be in full compliance with COVID-19 health and safety measures. Clive, Yvette, and their fellow Hamilton Marchers have set their fundraising goal at $40,000 to help further critical research for this deadly blood cancer that affects nine new Canadians every day.

To learn more about how this event will be working, please click here: https://secure3.convio.net/myecad/site/TR?fr_id=1233&pg=entry&s_locale=en_CA

About Myeloma

Multiple myeloma, also known as myeloma, is the second most common form of blood cancer. Myeloma affects a type of immune cell called the plasma cell, found in the bone marrow. Every day, nine Canadians are diagnosed, yet in spite of its growing prevalence, the disease remains relatively unknown. While there is no cure, people with myeloma are living longer and better lives, thanks to recent breakthroughs in treatment. To find the cure, more funding and research are required. To learn more, or to donate, please visit http://www.myeloma.ca.

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August 19th, 2020

Exosome Therapeutic Market (Covid 19 Impact Analysis) Data Highlighting Major Vendors, Promising Regions, Anticipated Growth Forecast To 2027 -…

By daniellenierenberg

Global Exosome Therapeutic Market By Type (Natural Exosomes, Hybrid Exosomes), Source (Dendritic Cells, Mesenchymal Stem Cells, Blood, Milk, Body Fluids, Saliva, Urine Others), Therapy (Immunotherapy, Gene Therapy, Chemotherapy), Transporting Capacity (Bio Macromolecules, Small Molecules), Application (Oncology, Neurology, Metabolic Disorders, Cardiac Disorders, Blood Disorders, Inflammatory Disorders, Gynecology Disorders, Organ Transplantation, Others), Route of administration (Oral, Parenteral), End User (Hospitals, Diagnostic Centers, Research & Academic Institutes), Geography (North America, Europe, Asia-Pacific and Latin America)

Exosome therapeutic market is expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

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This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for an Analyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.

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The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.

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August 19th, 2020

Global stem cell banking market Enhancement And Its growth prospects forecast 2020 to 2027 – Scientect

By daniellenierenberg

Global stem cell banking market is set to witness a substantial CAGR of 11.03% in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. The increased market growth can be identified by the increasing procedures of hematopoietic stem cell transplantation (HSCT), emerging technologies for stem cell processing, storage and preservation. Increasing birth rates, awareness of stem cell therapies and higher treatment done viva stem cell technology.

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Competitive Analysis:

Global stem cell banking market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of inflammatory disease drug delivery market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Key Market Competitors:

Few of the major competitors currently working in global inflammatory disease drug delivery market are: NSPERITE N.V, Caladrius, ViaCord, CBR Systems, Inc, SMART CELLS PLUS, LifeCell International, Global Cord Blood Corporation, Cryo-Cell International, Inc., StemCyte India Therapeutics Pvt. Ltd, Cordvida, ViaCord, Cryoviva India, Vita34 AG, CryoHoldco, PromoCell GmbH, Celgene Corporation, BIOTIME, Inc., BrainStorm Cell Therapeutics and others

Market Definition:Global Stem Cell Banking Market

Stem cells are cells which have self-renewing abilities and segregation into numerous cell lineages. Stem cells are found in all human beings from an early stage to the end stage. The stem cell banking process includes the storage of stem cells from different sources and they are being used for research and clinical purposes. The goal of stem cell banking is that if any persons tissue is badly damaged the stem cell therapy is the cure for that. Skin transplants, brain cell transplantations are some of the treatments which are cured by stem cell technique.

Cord Stem Cell Banking MarketDevelopment and Acquisitions in 2019

In September 2019, a notable acquisition was witnessed between CBR and Natera. This merger will develop the new chances of growth in the cord stem blood banking by empowering the Nateras Evercord branch for storing and preserving cord blood. The advancement will focus upon research and development of the therapeutic outcomes, biogenetics experiment, and their commercialization among the global pharma and health sector.

Cord Stem Cell Banking MarketScope

Cord Stem Cell Banking Marketis segmented on the basis of countries into U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

All country based analysis of the cord stem cell banking marketis further analyzed based on maximum granularity into further segmentation. On the basis of storage type, the market is segmented into private banking, public banking. On the basis of product type, the market is bifurcated into cord blood, cord blood & cord tissue. On the basis of services type, the market is segmented into collection & transportation, processing, analysis, storage. On the basis of source, market is bifurcated into umbilical cord blood, bone marrow, peripheral blood stem, menstrual blood. On the basis of indication, the market is fragmented into cerebral palsy, thalassemia, leukemia, diabetes, autism.

Cord stem cell trading is nothing but the banking of the vinculum plasma cell enclosed in the placenta and umbilical muscle of an infant. This ligament plasma comprises the stem blocks which can be employed in the forthcoming time to tackle illnesses such as autoimmune diseases, leukemia, inherited metabolic disorders, and thalassemia and many others.

Market Drivers

Increasing rate of diseases such as cancers, skin diseases and othersPublic awareness associated to the therapeutic prospective of stem cellsGrowing number of hematopoietic stem cell transplantations (HSCTs)Increasing birth rate worldwide

Market Restraint

High operating cost for the therapy is one reason which hinders the marketIntense competition among the stem cell companiesSometimes the changes are made from government such as legal regulations

Key Pointers Covered in the Cord Stem CellBanking MarketIndustry Trends and Forecast to 2026

Market SizeMarket New Sales VolumesMarket Replacement Sales VolumesMarket Installed BaseMarket By BrandsMarket Procedure VolumesMarket Product Price AnalysisMarket Healthcare OutcomesMarket Cost of Care AnalysisMarket Regulatory Framework and ChangesMarket Prices and Reimbursement AnalysisMarket Shares in Different RegionsRecent Developments for Market CompetitorsMarket Upcoming ApplicationsMarket Innovators Study

Key Developments in the Market:

In August, 2019, Bayer bought BlueRock for USD 600 million to become the leader in stem cell therapies. Bayer is paying USD 600 million for getting full control of cell therapy developer BlueRock Therapeutics, promising new medical area to revive its drug development pipeline and evolving engineered cell therapies in the fields of immunology, cardiology and neurology, using a registered induced pluripotent stem cell (iPSC) platform.In August 2018, LifeCell acquired Fetomed Laboratories, a provider of clinical diagnostics services. The acquisition is for enhancement in mother & baby diagnostic services that strongly complements stem cell banking business. This acquisition was funded by the internal accruals which is aimed to be the Indias largest mother & baby preventive healthcare organization.

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Research objectives

To perceive the most influencing pivoting and hindering forces in Cord Stem Cell Banking Market and its footprint in the international market.Learn about the market policies that are being endorsed by ruling respective organizations.To gain a perceptive survey of the market and have an extensive interpretation of the Cord Stem Cell Banking Market and its materialistic landscape.To understand the structure of Cord Stem Cell Banking Market by identifying its various sub segments.Focuses on the key global Cord Stem Cell Banking Market players, to define, describe and analyze the sales volume, value, market share, market competition landscape, SWOT analysis and development plans in next few years.To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).To project the consumption of Cord Stem Cell Banking Market submarkets, with respect to key regions (along with their respective key countries).To strategically profile the key players and comprehensively analyze their growth strategiesTo analyze the Cord Stem Cell Banking Market with respect to individual growth trends, future prospects, and their contribution to the total market.

Customization of the Report:

All segmentation provided above in this report is represented at country levelAll products covered in the market, product volume and average selling prices will be included as customizable options which may incur no or minimal additional cost (depends on customization)

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Global stem cell banking market Enhancement And Its growth prospects forecast 2020 to 2027 - Scientect

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August 19th, 2020

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